Adam Slivka1, Ian Gan2, Priya Jamidar3, Guido Costamagna4, Paola Cesaro4, Marc Giovannini5, Fabrice Caillol5, Michel Kahaleh6. 1. Division of Gastroenterology, Hepatology & Nutrition, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, USA. 2. Digestive Disease Institute, Gastroenterology and Hepatology Colorectal cancer, Virginia Mason Bellevue Clinic, Seattle, Washington, USA. 3. Section of Digestive Diseases, New Haven, Connecticut, USA. 4. Ambulatorio di Endoscopia e Fisiopatologia Digestiva Chirurgica, Policlinico Policlinico Universitario Agostino Gemelli, Roma, Italy. 5. Service d'Endoscopie, Institut Paoli Calmettes, Marseille, France. 6. Division of Gastroenterology & Hepatology, Weill Cornell Medical College, New York, New York, USA.
Abstract
BACKGROUND: Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study. OBJECTIVE: To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures. DESIGN: Prospective, international, multicenter study. SETTING: Six academic centers. PATIENTS: A total of 136 patients with indeterminate biliary strictures. INTERVENTIONS: Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months. MAIN OUTCOME MEASUREMENTS: Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling. RESULTS: A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy. LIMITATIONS: No randomization of care maps. pCLE not blinded. CONCLUSION: pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01392274.).
BACKGROUND: Characterization of indeterminate biliary strictures remains problematic. Tissue sampling is the criterion standard for confirming malignancy but has low sensitivity. Probe-based confocal laser endomicroscopy (pCLE) showed excellent sensitivity in a registry; however, it has not been validated in a prospective study. OBJECTIVE: To prospectively validate pCLE in real time during ERCP for indeterminate biliary strictures. DESIGN: Prospective, international, multicenter study. SETTING: Six academic centers. PATIENTS: A total of 136 patients with indeterminate biliary strictures. INTERVENTIONS: Investigators provided a presumptive diagnosis based on the patient history, ERCP impression, and pCLE during the procedure before and after tissue sampling results were available. A presumptive diagnosis also was made separately by a blinded investigator during ERCP and after tissue sampling to estimate care without pCLE. Follow-up was at least 6 months. MAIN OUTCOME MEASUREMENTS: Accuracy, sensitivity, and specificity during ERCP alone, ERCP with pCLE, and ERCP with pCLE and tissue sampling. RESULTS: A total of 112 patients were evaluated (71 with malignant lesions). Tissue sampling alone was 56% sensitive, 100% specific, and 72% (95% confidence interval [CI], 63%-80%) accurate. pCLE with ERCP was 89% sensitive, 71% specific, and 82% (95% CI, 74%-89%) accurate. After tissue sampling returned, strictures could be characterized with 88% (95% CI, 81%-94%) accuracy. LIMITATIONS: No randomization of care maps. pCLE not blinded. CONCLUSION:pCLE provided a more accurate and sensitive diagnosis of cholangiocarcinoma compared with tissue sampling alone. Incorporation of pCLE into the diagnostic armamentarium of patients with indeterminate biliary strictures may allow for a more accurate assessment, potentially reducing delays in diagnosis and costly repeat testing. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01392274.).
Authors: Mazen R Al-Mansour; Antonio Caycedo-Marulanda; Brian R Davis; Abdulrahim Alawashez; Salvatore Docimo; Alia Qureshi; Shawn Tsuda Journal: Surg Endosc Date: 2020-05-13 Impact factor: 4.584